Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity. The exposure was for a period of 24-hours and under occlusion. The test substance was not moistened to ensure optimal contact with the skin. However in 6 animals the skin was abraded and no reaction occured. Therefor the negative outcome of this test is acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Perkadox 24
di-cetyl peroxydicarbonate
solid
storage at -20°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded, both clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours after application the skin reaction is scored.
Number of animals:
12, 6 with intact skin and 6 with abraded skin
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 1x1 inch
- Type of wrap if used: The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped. with an impervious material

REMOVAL OF TEST SUBSTANCE: the test substance is removed, no further details.
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 hours after application
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin reaction observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No effects on the skin were observed.
Executive summary:

12 new zealand white rabbits were exposed to the test substance for 24 hours under occulsion on thier backs. 6 animals has abraded skin and 6 animals had intact skin. 24 and 72 hours after application no effects on the skin were observed.